Clinical Trial Details (PDF Generation Date :- Sat, 24 Nov 2018 15:12:21 GMT) CTRI Number Last Modified On 22/10/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2013/04/003572 [Registered on: 22/04/2013] - Trial Registered Prospectively No Interventional Medical Device Single Arm Trial A study to test the efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound in reducing pain associated with painful bone cancer Magnetic Resonance-Guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases - a Multicenter Study Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) Details of Principal Investigator Dr Bhavin Jankharia Site Principal Investigator Piramal tower Annexe G K Marg Lower Parel bhavin@jankharia.com Details Contact Person (Scientific Query) Dr Bhavin Jankharia Site Principal Investigator Piramal Tower Annexe G K Marg Lower Parel bhavin@jankharia.com Details Contact Person (Public Query) Dr Avinash Auti Site Coordinator Piramal Tower Annexe G K Marg Lower Parel avinash.auti@srl.in page 1 / 5
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent > Sponsor: Philips Medical Systems MR Finland Type of Sponsor List of Countries Netherlands United Kingdom of Principal Investigator Avinash Auti SRL Diagnostics - Jankharia Imaging Source of Monetary or Material Support Primary Sponsor Details Philips Medical Systems MR Finland Äyritie 4 01510 Vantaa Finland Other [Medical Devices Industry - Global] of Site Site // Piramal Tower Annexe G K Marg Lower Parel - 09820616548 avinash.auti@srl.in of Committee Approval Status Date of Approval Is Independent Ethics Committee? SRL Diagnostics Ethics Committee Status Health Type Patients Approved 28/09/2012 No Date No Date Specified Condition Painful Bone Metastases Type Details Intervention Sonalleve MR-HIFU for Palliation of Painful Bone Metastases Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU) is a non-invasive outpatient modality being investigated for pain palliation in bone metastases. An ultrasound transducer is used to focus a beam of ultrasound energy into a small volume at a specific target site in the body. The focused beam is intended to produce therapeutic hyperthermia in the target field while only harmlessly warming the immediately surrounding tissue. Magnetic Resonance Imaging (MRI) is used during the procedure to aim the ultrasound beam and perform real-time thermal mapping at and around the target. Subjects enrolled in the trial will receive a single MR-HIFU treatment session on the most painful of their bone page 2 / 5
Inclusion Criteria Exclusion Criteria metastases. Local denervation and pain palliation of the targeted metastasis is typically achieved in the temperature range 55-70 degrees Celsius. HIFU is applied non-invasively through the skin. The HIFU procedure is performed as out-patient treatment. The procedure itself lasts typically 2-3 hours, with additional time required for patient preparation and recovery. Typically patients can return home the same day. Comparator Agent none This study is a single-arm study, and all study subjects will undergo the MR-HIFU procedure. The study is appropriately powered to allow comparison of the reported success rates against placebo pain palliation results from the scientific literature. Age From Age To Gender Details Details 18.00 Year(s) 99.00 Year(s) Both Inclusion Criteria Men and women with age 18 years or older Patient capable of giving informed consent and able to attend study visits Weight less than 140kg Radiologic evidence of bone metastases from any solid tumor Diagnosis of dominant painful bone metastasis (NRS 4 or more), either refractory to standard of care (including radiotherapy and optimal pain medication) or standard of care is contra-indicated or refused by patient. Patient has been on stable pain medication for at least 1 week prior to HIFU treatment date Pain is localized to the targeted area, or is likely to be referred pain arising from the targeted area Patient has 1-3 painful lesions, and only the most painful lesion will be treated Intended Target Volume accessible for MR-HIFU procedure Target lesion maximum dimension less or equal 8cm Intended target volume visible by non-contrast MR imaging Distance between target and skin greater or equal 1cm Patient is able to communicate sensation during MR-HIFU treatment MR-HIFU treatment date greater or equal 4 weeks from last local treatment of the target lesion MR-HIFU treatment date greater or equal 4 weeks from participation in another clinical trial Exclusion Criteria Patients with the following Exclusion Criteria cannot be enrolled in the study: Planned treatment lesion is a primary bone tumor or due to lymphoma, multiple myeloma, or leukemia. Communication barrier present page 3 / 5
Method of Generating Random Sequence Method of Concealment Blinding/Masking Unable to tolerate required stationary position during treatment Need for surgical stabilization in case of (impending) fracture (lytic lesion in weight-bearing bone larger than 50 percent of bone diameter) Pregnant woman Pain related to target lesion is predominantly due to fracture or impending fracture Pain related to target lesion is due to involvement of a neighboring major nerve by the metastatic tumor (cord or nerve compression) Target less than 3cm from bladder / bowel / nerve along the beam path and less than 1cm in the plane orthogonal to the beam Target in contact with hollow viscera Target located in skull, joints, ribs (when HIFU beam overlapping with lung), spine (excluding sacrum which is allowed) or sternum Scar along proposed HIFU beam path Internal or external fixation device along the proposed HIFU beam path or at the target MRI contraindicated (e.g. paramagnetic implants, pacemaker, claustrophobia) MRI contrast agent contraindicated (e.g. previous anaphylaxis or GFR less than 30 ml/min/1.73m2) Sedation contraindicated Previous surgery or minimally invasive treatment at targeted site Clinically relevant medical history or abnormal physical findings that could interfere with the safety of the participant as judged by the treating physician or investigator Primary Outcome Outcome Timepoints Pain Response to treatment on the Numerical Representative Scale (NRS 0-10) measured 30 days post treatment Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Complications / Safety Events, including Unintended Lesions on MRI Quality of Life on the EORTC-QLQ-C15-PAL scale Temporal evolution of pain response Subgroup analysis: pain response in radiation naive patients Exploratory Imaging Endpoint: change in lesion characteristics on X-ray and MRI Total Sample Size=62 Sample Size from =15 Post Marketing Surveillance 01/05/2013 11/01/2013 Years=2 Months=0 Days=0 Open to Recruitment throughout 90 day follow-up period 0, 7, 14, 30, 60 and 90 days post treatment during the first 30 days after treatment measured 30 days post-treatment 30, 60 and 90 days post-treatment page 4 / 5
Powered by TCPDF (www.tcpdf.org) PDF of Trial Recruitment Status of Trial () Publication Details Brief Summary Open to Recruitment The purpose of this study is to evaluate the effectiveness of the Philips Sonalleve Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) device for treating painful bone metastases. Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) is a non-invasive outpatient modality. In MR-HIFU, a specially designed ultrasound transducer is used to focus a beam of ultrasound energy into a small volume at a specific target site in the body. The focused beam is intended to produce therapeutic hyperthermia in the target field while only harmlessly warming the immediately surrounding tissue. Magnetic Resonance Imaging is used during the ultrasound treatment, both to focus the ultrasound beam on the target field and to perform real-time thermal mapping at and around the target. The Philips Sonalleve MR-HIFU system is a CE-marked device for the treatment of uterine fibroids and pain palliation of bone metastases. MR-HIFU may provide an alternative to radiotherapy or other ablative techniques for the palliation of painful bone metastases. The benefit of the HIFU treatment compared to radiotherapy or radiofrequency ablation is that it provides a low-risk, non-invasive, non-radiation therapy option, requiring no computed tomography (CT) for treatment planning or therapy. In addition, the treatment does not interfere with previous or planned radiation therapy or chemotherapy. Usually the first signs of improvement in pain response due to the HIFU treatment are observable within 1-2 weeks from the treatment.this may allow physicians to evaluate treatment effect relatively soon after treatment. The Philips Sonalleve MR-HIFU system is expected to be efficacious in reducing pain scores in patients with painful bone metastases and in reducing their pain medication usage. Demonstration of safety and effectiveness of the device in this study should enable pain palliation treatment with MR-HIFU to become available to a larger population of patients with painful bone metastases. References to previous HIFU trials on bone pain palliation: Catane R, Beck A, Inbar Y, et al. MR-guided focused ultrasound surgery (MRgFUS) for the palliation of pain in patients with bone metastases--preliminary clinical experience. Ann Oncol. 2007;18:163-7. Gianfelice D, Gupta C, Kucharczyk W, et al. Palliative treatment of painful bone metastases with MR imaging--guided focused ultrasound. Radiology. 2008;249:355-63. Liberman B, Gianfelice D, Inbar Y, et al. Pain palliation in patients with bone metastases using MR-guided focused ultrasound surgery: a multicenter study. Ann Surg Oncol. 2009;16:140-6. page 5 / 5